The following data is part of a premarket notification filed by Best Industries with the FDA for Implanters/adjustable/anderson's Markers.
| Device ID | K940121 |
| 510k Number | K940121 |
| Device Name: | IMPLANTERS/ADJUSTABLE/ANDERSON'S MARKERS |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | BEST INDUSTRIES 7643 FULLERTON RD. Springfield, VA 22153 |
| Contact | Sankara I Ramaswamy |
| Correspondent | Sankara I Ramaswamy BEST INDUSTRIES 7643 FULLERTON RD. Springfield, VA 22153 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-10 |
| Decision Date | 1994-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841365115226 | K940121 | 000 |
| 00841365107764 | K940121 | 000 |
| 00841365107740 | K940121 | 000 |
| 00841365107733 | K940121 | 000 |